FDA device listing
Accu-Chek Aviva test strips,Accu-Chek Guide Blood Glucose Monitoring System,Accu-Chek Guide test strips,Accu-Chek Inform…
FDA device listing 1000542536 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | Accu-Chek Aviva test strips,Accu-Chek Guide Blood Glucose Monitoring System,Accu-Chek Guide test strips,Accu-Chek Inform II test strips,Accu-Chek Instant test strips,Accu-Chek Performa test strips |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Product codes | LFR |
| Device names | LFR - Glucose Dehydrogenase, Glucose |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE DIABETES CARE, INC. |
| Establishment registrations | 3011393376 |
| FEI numbers | 3011393376 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database